Description of Event or Problem · 1
DATA INNOVATIONS, THE MFR OF INSTRUMENT MANAGER SOFTWARE, WAS NOTIFIED ON (B)(6) 2019 BY ROCHE DIAGNOSTICS THAT CHRISTINE HOLLAND, THE LEAD MEDICAL TECHNOLOGIST AT ST ELIZABETH HOSP REPORTED THAT THE FOLLOWING SCENARIO OCCURRED AT ST. ELIZABETH'S HOSP ON (B)(6) 2019: A SPECIMEN FOR PT A WAS COLLECTED AND LABELED WITH THE APPROPRIATE BARCODE. A SPECIMEN FOR PT B WAS COLLECTED AND LABELED APPROPRIATELY WITH PT B'S BARCODE. LATER, IN THE LAB, PT B'S SPECIMEN WAS RELABELED INCORRECTLY WITH A REPRINTED PT A BARCODE LABEL. A TROPONIN TEST, A CARDIAC HEALTH MARKER, WAS PERFORMED ON BOTH SPECIMENS AND THE RESULT OF PT B WAS REPORTED TO PT A'S CHART. NO RESULTS WERE REPORTED FOR PT B. THE LAB NOTICED PT B'S PENDING TROPONIN TEST ON THEIR PENDING LOG AND THE SPECIMEN WAS RECOLLECTED AND RUN. PT A WAS ADMITTED TO THE HOSP FOR FURTHER WORKUP BASED ON THE INCORRECT RESULTS. PT B WAS ALREADY IN-HOUSE AND HAD A HISTORY OF ELEVATED TROPONIN. BARCODES ARE GENERATED OUTSIDE OF INSTRUMENT MANAGER. THIS WAS USER ERROR IN APPLYING AN INCORRECT BARCODE TO A SPECIMEN. THIS IS NOT A MALFUNCTION OF INSTRUMENT MANAGER. REPORT IS BEING SUBMITTED DUE TO THE PT BEING ADMITTED TO THE HOSPITAL. FDA SAFETY REPORT ID# (B)(4).